Centre tightens regulation of alcohol-based medicinal formulations to curb misuse
New Delhi, July 10 (TNT): The Union Ministry of Health and Family Welfare has tightened regulatory oversight of medicinal formulations containing high concentrations of ethyl alcohol by withdrawing the existing exemption from licensing requirements for such products under the Drugs Rules, 1945.
The move is aimed at preventing the misuse of medicinal products with high alcohol content for intoxication while ensuring their continued availability for legitimate therapeutic use.
According to the Ministry, certain medicinal formulations, including tinctures of cardamom, ginger and other aromatic preparations, were exempted from licensing requirements under Schedule K of the Drugs Rules, 1945. Some of these products contain ethyl alcohol concentrations of up to 80-90 per cent v/v, making them vulnerable to diversion and misuse.
The Ministry said several State Governments had also raised concerns over the issue.
Under the amended rules, formulations containing more than 12 per cent v/v ethyl alcohol in quantities exceeding 30 ml will no longer be eligible for exemption under Schedule K. Manufacturers and sellers of such products will now be required to obtain the necessary licences under the Drugs and Cosmetics Act, 1940.
The amendment also places these formulations under Schedule H1 of the Drugs Rules, 1945, making them prescription-only medicines. Their sale will require a prescription from a registered medical practitioner, along with stricter record-keeping by pharmacies.
The Ministry said the amendment would strengthen regulatory oversight by ensuring that alcohol-containing medicinal products are supplied only through the regulated pharmaceutical supply chain, thereby reducing the risk of diversion and misuse.
The government said the measure forms part of its ongoing efforts to strengthen the country’s drug regulatory framework, promote the rational and responsible use of medicines and safeguard public health.
The amendments have been notified through a Gazette notification issued by the Ministry.
TNT TS
